Publication: Efficacy and tolerability of proteolytic enzymes as an anti-inflammatory agent in lymphoedema after axillary dissection due to mammary cancer: Difference between revisions
Created page with "{{Publication |Title=Efficacy and tolerability of proteolytic enzymes as an anti-inflammatory agent in lymphoedema after axillary dissection due to mammary cancer |Topic=Enzymes (bromelain papain) |Author=Kasseroller, R; Wenning, HG |Year=2003 |Journal=The European Journal of Lymphology and related problem |DOI=- |Authors Abstract=Aim of the study was to investigate the influence of a proteolytic enzyme, the drug Wobenzym, (Mucos Emulsionsges. mbH, Wien. Austria), on the..." |
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|Journal=The European Journal of Lymphology and related problem | |Journal=The European Journal of Lymphology and related problem | ||
|Authors Abstract=Aim of the study was to investigate the influence of a proteolytic enzyme, the drug Wobenzym, (Mucos Emulsionsges. mbH, Wien. Austria), on the volume of the lmyphoedema in the limb and the fibrotic changes in the tissue in secondary lymphoedema patients after axillary lymph node dissection due to mammary cancer who received combined decongestive physical treatment (CDT). Methods: Randomised, placebo controlled, double blinded study, carried out over one year in a lymphoedema treatment centre. 88 patients have been included and analysed according to the blind review report using a univariate one sided Wilcoxon Mann Whitney test for differences for the primary criterion volume reduction (confirmatory analysis). The secondary variables CRP value in the blood, skinfold thickness, tension, and global judgement of efficacy by both the investigator and patient underwent exploratory interpretations. The visits for measurements were scheduled on the days 1, 9, 19 and 45, except for CRP measurement which was performed on days 1 and 19 only. The CDT was applied from day 1 through day 20. | |||
|Authors Abstract=Aim of the study was to investigate the influence of a proteolytic enzyme, the drug Wobenzym, (Mucos Emulsionsges. mbH, Wien. Austria), on the volume of the lmyphoedema in the limb and the fibrotic changes in the tissue in secondary lymphoedema patients after axillary lymph node dissection due to mammary cancer who received combined decongestive physical treatment (CDT). | Results: Volume: Starting with baseline measurement of the ill arm of a mean of 2483.0 (verum) and 2420.1 (placebo) both groups show a decrease of volume until day 45 with final means of 2275.1 (verum) and 2225.7 (placebo). | ||
CRP: In patients with positive CRP-values at baseline there has been a mean percent change from baseline of minus 39.8% as compared to visit 3, while in the placebo group there has been a percent change of minus 17.4%. | |||
Skinfold Thickness: A parameter for the fibrosis. Starting with baseline thickness in the lower arm of 3.7mm (verum) and 5.0mm (placebo) both groups show decrease of the thickness until day 45 with final means of 3.0mm (verum) and 4.0mm (placebo). The mean percent change at the final visit 4 from visit 3 was shown with -0.19% for the verum group. The placebo group showed a marginal mean increase at the visit 4 from visit 3 with +2.2%. Starting with a baseline thickness of the skin of the hand of 6.5mm (verum) and 4.3mm (placebo) both groups show decrease of the thickness until day 45 with final means of 3.8mm (verum) and 3.0mm (placebo). The verum group is showing a better development with regard to the means between visit 2 and visit 4. In the upper arm and the fingers no group difference in decreasing the skinfold thickness was shown. | |||
Tension: It was assessed by the investigator by means of a 4-point scale. Starting with a baseline mean tension of 2.0 (verum) and 1.8 (placebo) both groups show a decrease of tension until visit 4 with final means of 0.4 (verum) and 0.5 (placebo). | |||
Conclusion: For the primary criterion Volometer measurements the study failed to demonstrate efficacy of the test preparations Wobenzym. The difference in volume reduction between the two groups is negligible. Nevertheless, fibrotic changes have far better been reduced in the verum group, not from the very beginning of the treatment, but in the second half of the treatment, meaning that the result of the CDT maintains better. The inflammation related parameters (tension, CRP) have a better outcome in the verum group compared to the placebo. The CDT is the golden standard in lymphoedema treatment, an improvement by anti-inflammatory therapy with proteolytic enzymes seems to be possible. | |||
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Latest revision as of 10:14, 30 September 2024
| Reference | |
|---|---|
| Title | Efficacy and tolerability of proteolytic enzymes as an anti-inflammatory agent in lymphoedema after axillary dissection due to mammary cancer |
| Topic | Enzymes (bromelain papain) |
| Author | Kasseroller, R, Wenning, HG |
| Year | 2003 |
| Journal | The European Journal of Lymphology and related problem |
| DOI | |
Author's Abstract The abstract and the information and conclusions contained therein were written by the authors of the publication.
| Aim of the study was to investigate the influence of a proteolytic enzyme, the drug Wobenzym, (Mucos Emulsionsges. mbH, Wien. Austria), on the volume of the lmyphoedema in the limb and the fibrotic changes in the tissue in secondary lymphoedema patients after axillary lymph node dissection due to mammary cancer who received combined decongestive physical treatment (CDT). Methods: Randomised, placebo controlled, double blinded study, carried out over one year in a lymphoedema treatment centre. 88 patients have been included and analysed according to the blind review report using a univariate one sided Wilcoxon Mann Whitney test for differences for the primary criterion volume reduction (confirmatory analysis). The secondary variables CRP value in the blood, skinfold thickness, tension, and global judgement of efficacy by both the investigator and patient underwent exploratory interpretations. The visits for measurements were scheduled on the days 1, 9, 19 and 45, except for CRP measurement which was performed on days 1 and 19 only. The CDT was applied from day 1 through day 20.
Results: Volume: Starting with baseline measurement of the ill arm of a mean of 2483.0 (verum) and 2420.1 (placebo) both groups show a decrease of volume until day 45 with final means of 2275.1 (verum) and 2225.7 (placebo). CRP: In patients with positive CRP-values at baseline there has been a mean percent change from baseline of minus 39.8% as compared to visit 3, while in the placebo group there has been a percent change of minus 17.4%. Skinfold Thickness: A parameter for the fibrosis. Starting with baseline thickness in the lower arm of 3.7mm (verum) and 5.0mm (placebo) both groups show decrease of the thickness until day 45 with final means of 3.0mm (verum) and 4.0mm (placebo). The mean percent change at the final visit 4 from visit 3 was shown with -0.19% for the verum group. The placebo group showed a marginal mean increase at the visit 4 from visit 3 with +2.2%. Starting with a baseline thickness of the skin of the hand of 6.5mm (verum) and 4.3mm (placebo) both groups show decrease of the thickness until day 45 with final means of 3.8mm (verum) and 3.0mm (placebo). The verum group is showing a better development with regard to the means between visit 2 and visit 4. In the upper arm and the fingers no group difference in decreasing the skinfold thickness was shown. Tension: It was assessed by the investigator by means of a 4-point scale. Starting with a baseline mean tension of 2.0 (verum) and 1.8 (placebo) both groups show a decrease of tension until visit 4 with final means of 0.4 (verum) and 0.5 (placebo). Conclusion: For the primary criterion Volometer measurements the study failed to demonstrate efficacy of the test preparations Wobenzym. The difference in volume reduction between the two groups is negligible. Nevertheless, fibrotic changes have far better been reduced in the verum group, not from the very beginning of the treatment, but in the second half of the treatment, meaning that the result of the CDT maintains better. The inflammation related parameters (tension, CRP) have a better outcome in the verum group compared to the placebo. The CDT is the golden standard in lymphoedema treatment, an improvement by anti-inflammatory therapy with proteolytic enzymes seems to be possible. |
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